Scenario: A doctor is about to inject an aseptically manufactured injectable finished pharmaceutical into the arm of a child.
Examine the graphical representation on the next page for “A Validation Approach for a Complex Project, Consisting of Many Systems and Components”.
Briefly describe the inter-relationships between the following operational activities for a computerized system in a GxP environment.
Examine the diagram on the next page for a typical vertical processing facility designed for batch API production.
Describe, with reference to the diagram, how synthetic API plants (Batch Organic Chemical Synthesis) normally follow a sequence to produce a solid product:
Study the following diagram that represents the basic unit operations that most companies implement when manufacturing a biopharmaceutical protein-based drug substance.
Briefly describe the following three stages of a typical process:
Describe the principals for a typical cleaning validation sequence as listed below:
Describe the primary process principals of a typical pharmaceutical tableting operation. List three (3) critical parameters that must be controlled.
Combining the principals of the FDA’s approach to medical device classifications with the EU Medical Device Directive 93/42/EEC, list three devices in the following categories giving reasons for your answers: